FDA_RFI_75F40124Q00013.pdf

REQUEST FOR INFORMATION #FDA-RFI- Sol #75F40124Q00013

FOR: Reducing Risks of Compounded Drugs: Online Training Support Learning Management System

(LMS)

DEPT/AGENCY INFORMATION: Department of Health and Human Services U.S. Food and Drug Administration

Requiring Offices: The Center for Drug Evaluation and Research (CDER) The Office of Compliance (OC)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this request for information (RFI)RFI as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing a Learning Management System (LMS).

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ) and does not commit the Government to award a contract now or in the future. The purpose of this sources sought is to identify Small Businesses with the capabilities to provide the services stated herein. Submission of any information in response to this market survey is purely voluntary and FDA welcomes responses from all interested parties; the Government assumes no financial responsibility for any costs incurred.

s The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the objectives described in this notice. The FDA does not intend to make a selection decision or award a contract on the basis of responses. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

Respondents will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Responses should be emailed to Brian Wodzisz, Contract Specialist, at Brian.Wodzisz@fda.hhs.gov by 2pm EST, October 26th, 2023.

Please include the RFI number FDA-RFI-75F40124Q00013 Learning Management System (LMS) in the subject line. No phone calls will be accepted for this notice.

OBJECTIVE or DRAFT STATEMENT OF WORK

As a direct result of a future contract, the FDA expects to accomplish the following objectives:

• Provide services to host, manage, and administer self-guided, online web-based training.

• Provide the expertise, services and support necessary to maintain the Learning Management

System (LMS) requirements listed below:

o Ability for CDER OC staff to post courses visible to all users of the learning management system or a specific group of users.

o Entirely web-based with no need for users to install extra software or plug-ins.

o Ability to host both SCORM-compliant and non-SCORM compliant content.

o Ability to migrate data, including existing user, content, or course data to the LMS.

o The LMS shall be housed outside the FDA’s internal network to allow external (non-governmental) users access.

o Ability to host an unlimited number of separate courses and manage an unlimited number of users and allow for nearly 24/7 user access to those courses.

o Ability to track individual learner progress, course attendance and create detailed student transcripts with a complete learning history.

o An interface to create custom reports to monitor and track user progress, course completions and course evaluations.

o Create, assign, and manage pre- and post-assessments and evaluations.

o Ability to communicate with LMS users through targeted email announcements.

o Create an CDER/OC-branded portal.

o Ability to provide detailed student transcripts with complete learning history.

o Manage LMS users through designated subgroups.

o Ability to assign admin roles to CDER OC users.

o Create and assign training plans for learners and groups of learners.

o Ability to provide continuing education credits.

o Availability of technical support through email or phone.

o Ability to provide recovery of data and all course content due to the occurrence of a malfunction, power outage, or other event leading to loss of electronic files /redundancy of electronic file storage

• Make recommendations and updates to Learning Management System (LMS) resulting in continual performance improvements.

BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make biologics, medicines, and foods more effective, safer, and more affordable; and helping the public access accurate science-based information for drug products and foods. The FDA’s mission is to ensure the safety purity, potency, and effectiveness of all regulated products. The agency is committed to providing the public with accurate, timely and easy to understand information on agency policies, programs, and actions.

The Center for Drug Evaluation and Research’s (CDER) mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, they meet established quality standards and that they are available to patients. CDER’s Office of Compliance (OC) plays a critical role in protecting and promoting public health in shielding patients from poor quality, unsafe and ineffective drugs. The complexity of the human drug supply and development pipeline and the global nature of regulated industry present unprecedented challenges to effective regulatory oversight. CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality) and other offices at the FDA (such as the Office of Regulatory Affairs) work together to advance FDA’s work related to drug compounding.

Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health.

The Drug Quality and Security Act (DQSA) of 2013 established a sector of compounders, named "outsourcing facilities", under section 503B of the Food, Drug and Cosmetic Act that must meet more stringent quality standards to produce products on a larger scale. This new industry sector of drug compounders is held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. Ten years since its creation, this domestic industry is still relatively small (approximately 75 entities) and is experiencing growth and market challenges.

FDA, using a special Congressional appropriation, established the Compounding Quality Center of Excellence to engage in several initiatives to address challenges faced by the Outsourcing Facility (OF) industry and help the industry meet its intended function of providing high quality drugs needed by patients. The Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC) in the FDA Center for Drug Evaluation and Research (CDER) currently operates the Compounding Quality Center of Excellence (CQCOE).

The CQCOE Training Program, one of the initiatives, was successfully launched in the fall of 2020 to provide education and training for the OF industry and other stakeholders. As this industry continues to experience challenges, and FDA continues to find issues concerning drug quality and safety during inspections, the Agency recognizes the importance of expanding its CQCOE Training Program to address these challenges. This includes the need to develop and deliver new, and revise existing, CGMP training courses and ensure access to CGMP training for all 503B compounding stakeholders (e.g., OFs, compounders, federal and state regulators).

The CQCOE Training Program includes the development and provision of practical, virtual, and self-guided online training tailored to the outsourcing facility industry in the realm of Current Good

Manufacturing Practice (CGMP). To date, the COE has a portfolio of six live, instructor-led virtual trainings (ILT), ten self-guided online trainings, and two laboratory-based trainings developed prior to the start of the COVID-19 pandemic. These courses have been well attended and are widely utilized by outsourcing facilities. A Learning Management System (LMS) will be required to house both the instructor-led and self-guided online, web-based trainings for stakeholders (users) to access trainings.

PLACE OF PERFORMANCE:

All work can be accomplished at the Contractor's facility.

Companies are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential Offerors are encouraged to respond to this notice.

However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required.

Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to perform effectively and efficiently each of the objectives described above at a sufficient level of detail to allow definitive numerical evaluation.

Responses to this notice shall be limited to 10 pages, and must include:

1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses.

3. Business size for NAICS 541519 with size limitation standards of $34,000,000.00.

4. SAM UEI number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) at www.sam.gov to be considered as potential sources.

5. Identification of the firm’s GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested.

6. If the company has a Government approved accounting system, please identify the agency that approved the system.

Please provide responses to the following questions regarding capability/experience relevant to providing services for the learning management system:

1. What experience/capability do you have with managing, hosting, and administering web-based training for large groups? Please provide examples with explanation.

http://www.sam.gov/

2. What experience do you have with hosting open-access web-based training that can be utilized by the general public? Please provide examples.

3. Have you created specialized, public-facing web-based training content following 508 compliance standards? Please provide examples with explanation.

4. What changes, additions, updates, and clarification would you suggest for the draft statement of work?

5. What is your ability to collect and report data on users such as course completions and demographics?

6. What support is provided to resolve user issues? How long will users have to wait for assistance or resolution?

7. How will the LMS keep content and user data secure?

Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above).

To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure.

This announcement is Government market research and may result in revisions in both its requirements and its acquisition strategy based on industry responses.

It is emphasized that this is a notice for planning and information purposes only and is not to be construed as a commitment by the Government to enter into a contractual agreement, nor will the Government pay for information solicited.